A variety of manufacturing environments require strict control over the presence of foreign debris in the air. Semiconductor manufacturing, for example, has long required “clean-rooms” that use extensive air filtering to reduce the number and size of particles in the air to some acceptable level. Other manufacturing environments have similar but distinct requirements. For example, in pharmaceutical or medical device manufacturing environments it is critical to control not only the number of particles in the air, but minimization of biologic particles is of particular importance. Microbial contamination, for example, can render an entire batch of pharmaceutical product unusable leading to significant monetary losses in the manufacturing process. Additionally, it is advantageous to have instantaneous detection of contamination events, including instantaneous information about whether a contamination event is biologic or non-biologic, during the manufacturing process for pharmaceuticals or medical devices.
A variety of systems and methods exist that provide instantaneous detection of fluid borne particles. For example, certain detectors have been designed to detect fluid borne particles and provide warning when the number of particles within an air sample exceeds a predetermined minimum value. Exemplary devices are described in U.S. Pat. Nos. 5,646,597, 5,969,622, 5,986,555, 6,008,729, and 6,087,947, all to Hamburger et al. These detectors all involve direction of a light beam through a sample of environmental air such that part of the beam will be scattered by any particles in the air, a beam blocking device for transmitting only light scattered in a predetermined angular range corresponding to the predetermined allergen size range, and a detector for detecting the transmittal light. An alarm is actuated if the light detected at the detector is above a predetermined level.
Additionally, systems and methods exist that instantaneously determine whether detected particles are biologic or inert. For example, U.S. Pat. No. 7,430,046 to Jiang et al., discloses systems and methods for simultaneously measuring particle size by use of Mie scattering and determining whether the measured particles are biologic or inert by detecting fluorescence excited in certain biological chemicals present in the measured particles.
Although fluorescence analysis can, in certain cases, be used to determine the type of biologic particle detected, i.e., the type of organism, it would be advantageous to have additional systems and methods that could simultaneously collect information on particle size, whether a particle is biologic or non-biologic, and the type of biologic particle that has been detected.